This randomized controlled trial is designed to address gaps in couple-based HIV prevention research by focusing exclusively on HIV negative concordant couples where one or both partners are drug-involved. Building on prior couple-based HIV research that resulted in an evidence-based HIV prevention model for couples (Connect), intervention components were modified to address dyadic drug risk reduction and drug-related unsafe sex and a couple-based HIV risk reduction intervention (Connect II) was designed specifically for drug-involved, HIV negative concordant heterosexual couples at risk for HIV/STIs. For this RCT, couples are recruited primarily through street outreach in drug using locations and randomized into one of three arms: (1) couple-based HIV Risk Reduction condition; (2) individual-based HIV Risk Reduction, which delivered the same content as the couple-based condition but was provided to either the male or female drug-using partner alone; or (3) couple-based Wellness Promotion, which served as an attentional control arm. This RCT tests two major hypotheses: (1) whether the HIV risk reduction intervention provided to the couple or an individual partner would be more efficacious in decreasing number of unprotected acts of intercourse and having a lower cumulative incidence of biologically confirmed STIs over the 12-month follow-up period compared to the Wellness promotion control arm and (2) whether the couple-based HIV risk reduction intervention would be more likely to decrease the number of unprotected acts and have a lower cumulative STI incidence compared to the Individual HIV Risk reduction Arm.

Both identified each other as main, regular partner, boy/girlfriend, spouse, lover

Both reported that they have been together for at least 6 months

Both intended to remain together for at least one year

At least one partner reported using illicit drugs in the prior 90 days and was seeking or in drug treatment

At least one partner reported having had unprotected intercourse with the other in the prior 90 days.

Additionally, at least one partner had to report one or more of the following HIV risk criteria:

Having had sex with other partners in the prior 90 days

Injecting drugs in the prior 90 days; or

Self-report being diagnosed with an STI in the prior 90 days.

Exclusion Criteria:

Couples were excluded from the study:

If either partner reported experiencing severe intimate partner violence in the past year by the other partner as assessed by subscales of the Revised Conflict Tactics Scale

If either partner exhibited a severe cognitive or psychiatric impairment assessed during informed consent

If either partner did not have sufficient understanding of English

If either partner reported intentions to have a baby in the next year and to relocate beyond a reasonable distance from the study site in the coming year.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285349